FDA 510(k) Application Details - K142666

Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief

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510(K) Number K142666
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant Delta International Services & Logistics S.r.l
Piazza Cavour 17
Rome 00193 IT
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Contact Donatella Ruscito
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 09/18/2014
Decision Date 05/22/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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